Abstract
Background:Recruitment of general practices and their patients into research studies is frequently reported as a challenge. The Preventing and Lessening Exacerbations of Asthma in School-aged children Associated with a New Term (PLEASANT) trial recruited 142 general practices, across England and Wales and delivered the study intervention to time and target.Aims:To describe the process of recruitment used within the cluster randomised PLEASANT trial and present results on factors that influenced recruitment.Methods:Data were collected on the number of and types of contact used to gain expression of interest and subsequent randomisation into the PLEASANT trial. Practice size and previous research experience were also collected.Results:The mean number of contacts required to gain expression of interest were m=3.01 (s.d. 1.6) and total number of contacts from initial invitation to randomisation m=6.8 (s.d. 3.5). Previous randomised controlled trial involvement (hazard ratio (HR)=1.81 (confidence interval (CI) 95%, 1.55–2.11) P<0.001) and number of studies a practice had previously engaged in (odds ratio (OR) 1.91 (CI 95%, (1.52–2.42)) P<0.001), significantly influenced whether a practice would participate in PLEASANT. Practice size was not a significant deciding factor (OR=1.04 (95% CI 0.99–1.08) P=0.137).Conclusions:Recruitment to time and target can be achieved in general practice. The amount of resource required for site recruitment should not, however, be underestimated and multiple strategies for contacting practices should be considered. General practitioners with more research experience are more likely to participate in studies.
Highlights
Recruitment of general practices (GPs) and their patients into research studies is often reported as a challenge.[1,2,3] This difficulty in recruitment has a negative impact on recruitment targets, delivery to pre-planned timelines and associated costs, which can have implications for the validity of the findings and how representative they may be.[2,4]A survey of UK primary care studies reported that 56% of studies extended the recruitment period, 44% increased the number of sites, and 31% sought additional funding in order to complete the trial.[5]
Background to the PLEASANT trial In the United Kingdom, there is a significant increase in the number of unscheduled visits to the doctor, by school-aged children with asthma associated with the return back to school in September after the summer holidays
A staged recruitment strategy was undertaken by Clinical Practice Research Datalink (CPRD), which consisted of repeat invitations by post or email to all 433 practices from England and Wales contributing to the database
Summary
Recruitment of general practices (GPs) and their patients into research studies is often reported as a challenge.[1,2,3] This difficulty in recruitment has a negative impact on recruitment targets, delivery to pre-planned timelines and associated costs, which can have implications for the validity of the findings and how representative they may be.[2,4]A survey of UK primary care studies reported that 56% of studies extended the recruitment period, 44% increased the number of sites, and 31% sought additional funding in order to complete the trial.[5]. There has been published guidance on the principles of improving recruitment in primary care[2] and information from systematic reviews of recruitment in clinical trials generally,[6] the lack of evidenced-based recommendations makes targeting interventions for improving recruitment difficult As such the process of recruitment remains complex and challenging. PLEASANT is a cluster randomised controlled trial (cRCT) that examines whether a brief intervention delivered by the GP and the practice to the parents of school-aged children with asthma, at the start of the summer holidays, would reduce the number of Received 18 March 2015; revised 23 September 2015; accepted 3 October 2015 unscheduled medical contacts following return to school in research assistant and trial manager who are based in the Sheffield Clinical.
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